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Introduction to the ISO 13485:2016 - Awareness Training

Risk Management ISO 14971:2012

Introduction to the ISO 13485:2016 - Awareness Training with practical workshops and exam

About Introduction to the ISO 13485:2016 – Awareness Training

Why this training:

The ISO 13485:2016 became mandatory in March 2019 to fulfill for certification of Quality Management Systems. The aim of this training is to provide the participants with an understanding of the full standard. You should be given an introduction in how to apply and interpret the standard with the support of the practical guide for ISO 13485 (handbook) and TR 17223:2018 (GAP towards MDR/IVDR QMS expectations)

Who should attend:

Management, Design and development engineers, QA/RA specialists, Risk Managers, customer support/service, clinical support and marketing, contract manufacturer and component manufacturer as applicable. 

Course Leader:

Anette Sjögren, PREVENTIA AB

Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.

Language:

Course material and presentation is in English.

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Varighed:

The training is held online. Duration: 2 days

Pris:

Course fee: DKK 13.600,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

About Introduction to the ISO 13485:2016 – Awareness Training

Why this training:

The ISO 13485:2016 became mandatory in March 2019 to fulfill for certification of Quality Management Systems. The aim of this training is to provide the participants with an understanding of the full standard. You should be given an introduction in how to apply and interpret the standard with the support of the practical guide for ISO 13485 (handbook) and TR 17223:2018 (GAP towards MDR/IVDR QMS expectations)

Who should attend:

Management, Design and development engineers, QA/RA specialists, Risk Managers, customer support/service, clinical support and marketing, contract manufacturer and component manufacturer as applicable. 

Course Leader:

Anette Sjögren, PREVENTIA AB

Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.

Language:

Course material and presentation is in English.

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